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Fda Project Jobs in Nevada (NOW HIRING)

Assembler

Reno, NV · On-site

$16 - $19.75/hr

... projects * Adhere to general safety rules, manufacturing procedures, company policies and procedures, QSR, and FDA Regulations. * Identify and report any product quality problems * Facilitate ...

Effectively engage in project as the Quality Engineering resource. * Formulates or assists in ... FDA 21 CFR 820. * Auditing education and experience. * Ability to work effectively with various ...

Assembler

Reno, NV · On-site

$16 - $19.75/hr

... projects * Adhere to general safety rules, manufacturing procedures, company policies and procedures, QSR, and FDA Regulations. * Identify and report any product quality problems * Facilitate ...

Quality Engineer

Reno, NV

$71K - $92K/yr

Effectively engage in project as the Quality Engineering resource. * Formulates or assists in ... FDA 21 CFR 820. * Auditing education and experience. * Ability to work effectively with various ...

Quality Engineer

Reno, NV · On-site

$75K - $85K/yr

Effectively engage in project as the Quality Engineering resource. * Formulates or assists in ... FDA 21 CFR 820. * Auditing education and experience. * Ability to work effectively with various ...

You will manage system improvement projects, direct capital planning, and lead continuous ... optimization, FDA/GMP/AIB/SQF compliance, safety and automation. • Engage in the typical ...

Senior Manufacturing Engineer

Minden, NV · On-site

$91K - $125K/yr

Managing capital equipment projects from concept through installation, qualification, and ... Ensuring compliance with safety, regulatory, and quality standards (ISO 9001, AS9100, FDA, or ...

Senior Manufacturing Engineer

Minden, NV

$91K - $125K/yr

Managing capital equipment projects from concept through installation, qualification, and ... Ensuring compliance with safety, regulatory, and quality standards (ISO 9001, AS9100, FDA, or ...

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Fda Project information

What is an FDA Project?

An FDA Project typically refers to a project that involves compliance with the U.S. Food and Drug Administration (FDA) regulations. These projects can include developing, testing, or bringing to market medical products such as drugs, medical devices, biologics, or food items. The goal of an FDA Project is to ensure that products meet safety, efficacy, and quality standards set by the FDA before they are approved for public use. Such projects often require extensive documentation, clinical trials, and regulatory submissions to obtain FDA approval.

What is the difference between Fda Project vs Fda Reviewer?

AspectFda ProjectFda Reviewer
Required CredentialsTypically requires a background in life sciences, engineering, or related fields; often includes project management certificationsRequires a degree in life sciences, pharmacy, or medicine; often needs FDA-specific training or experience
Work EnvironmentProject teams within pharmaceutical or biotech companies, regulatory agencies, or consulting firmsRegulatory agencies, pharmaceutical companies, or biotech firms reviewing submissions
Employer & Industry UsageUsed in project management contexts to oversee regulatory submissions and complianceUsed in regulatory review processes to evaluate drug, device, or food applications

In summary, Fda Project roles focus on managing regulatory initiatives and ensuring compliance within organizations, while Fda Reviewers are responsible for evaluating and approving submissions directly for regulatory approval.

What are the key skills and qualifications needed to thrive as an FDA Project Manager, and why are they important?

To thrive as an FDA Project Manager, you need a strong background in regulatory affairs, project management, and a degree in life sciences or a related field. Familiarity with FDA submission requirements, electronic common technical document (eCTD) systems, and project management tools like MS Project or Asana is essential. Excellent communication, organization, and problem-solving abilities help manage cross-functional teams and ensure compliance. These skills ensure that projects meet regulatory standards, progress efficiently, and achieve timely FDA approvals.

What are some common challenges faced by professionals working on FDA project teams?

Professionals working on FDA project teams often encounter challenges related to regulatory compliance and shifting guidelines. Navigating complex documentation requirements, coordinating with cross-functional teams (such as clinical, regulatory, and quality assurance), and meeting strict submission deadlines are all common hurdles. Effective communication and adaptability are essential, as projects frequently involve collaboration across departments and ongoing updates based on regulatory feedback. Successfully managing these challenges helps ensure product approval and supports career advancement within regulatory affairs.
What are popular job titles related to Fda Project jobs in Nevada? For Fda Project jobs in Nevada, the most frequently searched job titles are:
What cities in Nevada are hiring for Fda Project jobs? Cities in Nevada with the most Fda Project job openings:
Assembler

$16 - $19.75/hr

Full-time

Posted 14 days ago


Job description

BHI Energy is searching for an assembler for a direct hire position.  If you have at least 1 or more years assembler experience in the medical device field or a related technical field, then this may be the right opportunity for you.  Company is growing and looking for more people to hire. 


Job Summary

  • Participate in production and development builds and manufacture high quality medical devices in accordance with released manufacturing documentation. 
  • Provide support as required in all phases of product development and transfer to manufacturing and commercial product.
  • Assemble plastic and metal components into medical devices in accordance with approved manufacturing procedures.
  • Perform in-process quality checks on sub-assemblies and finished product. 
  • Maintain clean room integrity by using proper attire and adherence to clean room environment  practices and procedures.
  • Maintain accurate records/documentation related to quality, work in progress, test results, labor (e.g. timecards) and special projects
  • Adhere to general safety rules, manufacturing procedures, company policies and procedures, QSR, and FDA Regulations.
  • Identify and report any product quality problems
  • Facilitate resolution of the non-conforming product until the deficiency or unsatisfactory condition has been resolved

Education and Experience 

  • 1 or more years assembler experience in the medical device field or a related technical field 
  • High school diploma or equivalent preferred
  • No medical conditions preventing access to a controlled environment.
  • High level of hand-eye coordination and manual dexterity
  • Must be able to handle small parts under a microscope
  • Trained, documented and proficient in MI's. 
Education:High School/GEDEmployment Type: FULL_TIME

BHI Energy logo

About BHI Energy

Sourced by ZipRecruiter

BHI Energy, situated in Weymouth, MA, US, is a prominent entity in the energy industry. The business, as detailed on bhienergy.com, specializes in delivering integrated power services and staffing solutions. BHI Energy's inception dates back to 1979 when it was established to address the needs of a rapidly growing energy market. BHI's commitment to its mission statement is reflected in its continuous dedication to meet and surpass customer expectations. The firm is devoted to delivering workforce solutions and focusing on maximizing asset value and reliability, which underlines its pursuit of operational excellence. BHI also boasts impressive achievements in the industry, with a reputation for offering the broadest scope of services via a nationwide network of locations across the United States.

Industry

Utilities

Company size

5,001 - 10,000 Employees

Headquarters location

Weymouth, MA, US

Year founded

1979

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